Registration Dossier

Administrative data

Description of key information

Crude Tall Oil was found to be not irritant to rabbit skin and eyes in reliable studies conducted according to the appropriate OECD test guidelines and in compliance with GLP (Wolf, 2005). 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

The only available study for skin irritation (reliability 1) was an in vivo test carried out in accordance with OECD Test Guideline 404 (Wolf, 2005). No skin reactions were observed up to and including the 72 hour observation. CTO was therefore judged to be non-irritant to rabbit skin.

Eye irritation:

The only available study for eye irritation (reliability 1) was an in vivo test carried out in accordance with OECD Test Guideline 405 (Wolf, 2005). Minor effects were observed at the 1 hour observation, but at no other time point. CTO was therefore judged to be non-irritant to rabbit eyes.

Skin corrosion:

The only available study specifically targeted at skin corrosion was an in vitro test carried out in accordance with OECD Test Guideline 430 (Weiss-Fuchs, 2005). The mean TER of Crude Tall Oil treated skins was 21.2 kΩ, which is above the threshold of 5 kΩ for classification.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on in vitro and in vivo data, CTO does not meet the criteria for classification as irritant or corrosive according to the criteria of EU Directive 67/548/EEC or Regulation 1272/2008.